Actively Recruiting

Phase Not Applicable
All Genders
NCT03645486

Lentiviral Gene Therapy for CGD

Led by Shenzhen Geno-Immune Medical Institute · Updated on 2026-04-24

10

Participants Needed

1

Research Sites

234 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a Phase I/II clinical trial of gene therapy for treating Chronic Granulomatous Disease using a high-safety, high-efficiency, self-inactivating lentiviral vector TYF to functionally correct the defective gene. The objectives are to evaluate the safety and efficacy of the TYF-CGD gene transfer clinical protocol.

CONDITIONS

Official Title

Lentiviral Gene Therapy for CGD

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with Chronic Granulomatous Disease (CGD) of any age
  • Molecular diagnosis confirmed by DNA sequencing supported by lab evidence showing absent or significantly reduced NADPH-oxidase activity
  • Karnofsky-Index score of 70% or higher
  • At least one prior, ongoing, or refractory severe infection or inflammatory complication requiring hospitalization despite drug treatment
  • Written informed consent from adult patients, and assent for pediatric subjects aged seven years or older
Not Eligible

You will not qualify if you...

  • Contraindications for leukapheresis such as anemia with hemoglobin less than 8 g/dl, cardiovascular instability, or severe coagulopathy
  • Contraindications for administration of conditioning medication
  • Female patients who are pregnant or breastfeeding as confirmed by history or positive pregnancy test

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, China, China

Actively Recruiting

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Research Team

L

Lung-Ji Chang, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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